Vascular Specialist@VAM–Conference Edition 3

Page 1


‘WE ARE IN THIS TOGETHER’: SVS PRESIDENT

SET TO ISSUE CALL FOR VASCULAR SURGERY UNITY

AMID TENSIONS OF MODERN MEDICINE

SVS PRESIDENT JOSEPH MILLS, MD, is set to issue a rallying call steeped in classical history and decades of collected vascular surgery wisdom in order to bring the specialty together for a common purpose: to overcome “unrest” and to drive forward vascular care.

Mills will tackle the consolidation of medicine into ever-larger for-profit enterprises, along with the stresses inherent within a body of people such as the SVS. In that way, he will tell his audience, it is no different than wider human society.

Mills’ 2023–24 presidency saw vascular disease enter the mainstream media spotlight in the context of the appropriateness—or inappropriateness—of vascular care. His address tackles the topic as he places the SVS and vascular surgery at the heart of efforts to ensure quality in vascular care.

Mills will invoke the democratic ideals of the ancient Greeks and how these principles drive collected interests in societies.

Mills is currently professor and chief of the Division of Vascular Surgery and Endovascular Therapy in the Michael E. DeBakey Department of Surgery at the Baylor College of Medicine in Houston. He started his vascular surgery career further west in Texas at Wilford Hall USAF

See page 2

CHICKASAW NATION STUDY EXEMPLIFIES HOW DIVERSITY CAN BOOST PATIENT ACCESS TO SPECIALIZED VASCULAR CARE

A“feasible and reproducible” intervention bundle characterized by surveys, provider education and patient screening has demonstrated the potential to not only identify gaps in peripheral arterial disease (PAD) primary care practices, but also to help address them. This was a salient concluding message delivered yesterday morning by Zoe Davis, a third-year medical student at the University

of Oklahoma (OU) in Tulsa, whose team set out to identify and reduce limb-amputation risks among Oklahoma’s Chickasaw Nation community.

VAM audience discussions around this research were led by Fernanda Costa Sampaio Silva, MD, a board-certified vascular surgeon and vascular sonographer at the Federal University of Bahia in Salvador, Brazil, who is also part of the SVS’ Diversity, Equity and Inclusion (DEI) Committee.

“Your work is an example of how diversity in vascular teams can improve patient access to specialized care,” Costa Sampaio Silva said. “By assessing primary care practices, a multi-professional vascular team can achieve impacts on early diagnosis and promote standardized PAD management among underserved populations.”

Costa Sampaio Silva also noted that, through the

See page 2

#VAM24Turntopage8fordailyplanner

Here’s what to look forward to in the final days of VAM 2024.

On Friday, general surgery residents will participate in a session covering how to be successful as a vascular fellowship applicant.

The International Fast Talk Session will begin at 7:15 a.m., followed by the Plenary Session 5. SVS President Joseph Mills, MD, will take to the podium at 11:00 a.m. for his Presidential Address

The afternoon will host sessions from the SVS Physician Assistants, Young Surgeons and Women’s Sections, as well as sessions covering CREST-2, vascular surgery leadership, infrainguinal bypass and more.

The Career Fair begins at 12:30 p.m. and residents are encouraged to attend the Residency Fair starting at 1:30 p.m.

The day closes with the International Young Surgeons Competition and the Poster Competition

The SVS Foundation Gala will occur this evening at the Museum of Science and Industry.

Saturday is the final dayof VAM, which will kick-off with the Plenary Session 7 with continental breakfast at 8 a.m., followed by the poster championship, second annual Frank Veith Distinguished Lecture, Plenary Session 8, and will wrap with the SVS Annual Business Meeting

Kristin Spencer

CHICKASAW

NATION STUDY

EXEMPLIFIES

HOW DIVERSITY CAN BOOST PATIENT ACCESS TO SPECIALIZED VASCULAR CARE

continued from page 1

study, vascular teams were able to establish a “bond” with the Chickasaw community— which, in turn, can improve patient trust and adherence to treatment. “So,” she added, “the ‘Caring For Our Feet’ program is a feasible and reproducible strategy that may serve as a model for further implementation in other communities, reducing disparities in access to vascular care.”

Caring For Our Feet

Speaking during yesterday morning’s Plenary Session 3, Davis—presenting on behalf of senior author Kelly Kempe, MD, associate professor of surgery at OU-Tulsa, and colleagues—began by outlining key motivations behind the study.

“A recent, 12-year review of our state’s hospital discharge data found that amputations—including major amputations—are on the rise in Oklahoma,” she said. “First Americans with a diagnosis of diabetes and/or PAD have one of the highest rates of lower-limb amputation.”

The speaker went on to note that, in an effort to combat limb loss and care disparities, multiple published guidelines have advocated multimodal approaches and consistently recommended provider education on PAD, and limb-loss prevention.

“Given this information, our OU-Tulsa multidisciplinary team partnered with the Chickasaw Nation to create a pilot outreach program,” Davis added, relaying that the project has “affectionately” been dubbed “Caring For Our Feet.” Its objective was to conduct a needs assessment of primary care practices, and it also sought to begin building a systems-based strategy for the early detection and prevention of PAD.

Davis and colleagues hypothesized that direct, in-person

FROM THE COVER ‘WE ARE IN THIS TOGETHER’: SVS PRESIDENT SET TO ISSUE CALL FOR VASCULAR SURGERY UNITY AMID TENSIONS OF MODERN MEDICINE

continued from page 1

Medical Center in San Antonio. Later, Mills helped lead efforts to establish a respected multidisciplinary limb salvage group known as SALSA, or the Southern Arizona Limb Salvage Alliance—a toe and flow model that paved a path for collaboration.

That same collaborative tone is at the heart of the message in his SVS address. “We are a small group, far too small to be splintered or fragmented,” he will say. Mills is looking to drive the conversation forward. “There is currently much unrest among physicians today in medicine,” he tells VS@VAM. “What is the root cause of this unrest? How should the SVS address it? My SVS Presidential Address will draw from lessons and insights offered by previous SVS presidents, Greek and Roman philosophers, modern authors—and even rock musicians—to outline the issues and chart a path forward.”

engagement would lead to a significant increase in awareness of amputation risks.

Their study involved conducting four standardized visits with each of the four Chickasaw Nation primary care clinics. Visit number one was completed virtually and involved the distribution of electronic pre-surveys, while visits two and three consisted of in-person sessions centered on provider and patient education, screening, and semi-structured

“We believe this is a viable strategy for the creation of a patient-to-provider-tospecialist network”
ZOE DAVIS

interviews. Their fourth and final visit was performed online and provided a “wrap-up,” feedback, and distribution of post-surveys.

All four Chickasaw Nation practices participated, Davis continued, also reporting an observed practitioner completion rate of 88% across their pre- and post-surveys. She stated that field notes indicated high receptivity and inquiry among participants based on lectures and discussions— and, overall, 27 out of 28 survey measures (96%) showed improvement, with 21 of these (75%) being statistically significant (p<0.05).

“From pre- to post-survey, we saw an improvement in clinicians’ self-reported comfort in treating, diagnosing and educating patients at risk for limb-loss due to chronic disease,” the presenter said.

Prior to concluding, Davis also reported that—across

the 20 high-risk patients recruited and identified by the clinics—screening revealed that 40% left with a new diagnosis of PAD.

“To summarize,” she said, “this early-needs assessment shows that there are practice gaps that, if addressed, could improve the prevention and, importantly, early management of patients who may be at risk for limb-loss. We believe this is a viable strategy for the creation of a patient-to-provider-to-specialist network, given the high practitioner engagement on our surveys, our survey measures showing improvement after our intervention, and our ability to newly diagnose PAD in patients identified by the clinic.”

Future directions

Providing an early window into where this research may lead, Davis then relayed that she and her colleagues are “in the process” of performing ongoing qualitative and quantitative analyses—as well as attempting to replicate the strategy with additional clinics. She added: “Our future plans are currently to expand this program more broadly across Oklahoma, to reach more people who may be at risk for limb-loss in their future, as well as—potentially, if successful—nationwide.”

When asked by Costa Sampaio Silva how the team may ‘upscale’ these strategies to state-wide or even national levels, Davis reported that feedback and direct engagement with the Chickasaw Nation community were a “very important” aspect of the present project.

According to Davis, these efforts ensured OU-Tulsa multidisciplinary teams were providing appropriate, implementable materials for the local community’s practice—and the same factors are likely to be vital in any attempts to scale the project up moving forward.

Young vascular surgeons on the PAD frontier:
‘This is the time to seize the day,’ 2024 Veith Lecturer declares

HUGE OPPORTUNITY ABOUNDS

for vascular surgeons to take a leadership role on the frontlines of a developing peripheral arterial disease (PAD) treatment crisis in the U.S., says Michael Conte, MD, on the eve of giving the second annual Frank J. Veith Distinguished Lecture on Saturday morning (10:45 –11:15 a.m. in the West Building, Level 3, Skyline Ballroom).

Conte is scheduled to talk on “The State of PAD Care in the U.S.,” and he took the opportunity to call on vascular surgeons to take a leadership role amid great unmet need among a population who face a significant public problem.

“There are a lot of exciting developments, and vascular surgery really needs to seize the day to lead in the science, lead in the challenges; it’s core to what we do, it’s core to our patient population,” the professor and chief of vascular and endovascular surgery at the

University of California San Francisco (UCSF) explains, speaking to VS@VAM on the sidelines of VAM 2024 ahead of the lecture.

“I think it’s a really great time for vascular surgeons to get involved, whether that’s in the clinical research, the disparities and access to care issues, amputation prevention programs, or multidisciplinary care.

“There’s a lot there for young vascular surgeons to embrace,” Conte continues. “The service part as well as the research part are significant. So, if you look at what’s happening at the SVS with the VISTA [Vascular Volunteers In Service To All] program, all the way through to promoting clinical trials in PAD, this is the time—it’s a generational thing.”

With carotid disease now “pretty stable,” and the strides made in aortic disease treatment meaning “we’ve solved a lot of stuff” in that domain, he says,

Michael Conte

many roads now lead to PAD, which he described as a “huge thing that needs a lot of help.”

First comes the opportunity, Conte declares, then the nature of the growing, countrywide public health problem— advancing age, diabetes not abating.

“We need to embrace and promote science-guided, evidence-based practice,” he says. “To do that, we have to continue to try to follow through on designing and executing clinical trials using our registries to address important issues of quality of care, and continue to write and update meaningful practice guidelines. It’s a multispecialty space and we should embrace that, not shy away from it. We should just lead.”

PREVIEW VEITH LECTURE

Heli-FX™ EndoAnchor™ System

Call in the reinforcements

ESAR with Heli-FX EndoAnchor System is your defense for patients at risk for suboptimal outcomes.

Reinforce the proximal seal1,2

Protect against neck dilatation3

Minimize Type Ia endoleaks4

Promote greater sac regression5

medtronic.com/ESAR

References

1 Melas N, Perdikides T, Saratzis A, Saratzis N, Kiskinis D, Deaton DH. Helical EndoStaples enhance endograft fixation in an experimental model using human cadaveric aortas.

J Vasc Surg. June 2012;55:1726-1733.

2 Schlösser FJV, de Vries JPPM, Chaudhuri A. Is it Time to Insert EndoAnchors into Routine EVAR? Eur J Vasc Endovasc Surg. April 2017;53:458-459.

3 Tassiopoulos AK, Monastiriotis S, Jordan WD, Muhs BE, Ouriel K, De Vries JP. Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors.

J Vasc Surg. July 2017;66:45-52.

4 ANCHOR 4-yr primary arm. 2019 data cut. Medtronic data on file.

5 Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors.

J Vasc Surg. June 2018;67(6):1699-1707.

HELI-FX™ & HELI-FX™ THORACIC ENDOANCHOR™ SYSTEMS

Indications for Use: The Heli-FX EndoAnchor system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX™ EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor™ implant may be implanted at the time of the initial endograft placement, or during a secondary (i.e. repair) procedure.

Contraindications: Treatment with the Heli-FX™ EndoAnchor™ system is contraindicated for use in the following circumstances: • In patients with known allergies to the EndoAnchor™ implant material (MP35N-LT) • In conjunction with the Endologix Powerlink endograft

Warnings: • The long-term performance of the EndoAnchor™ implant has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up visits to assess the patient’s health status and endograft performance. The EndoAnchor implant does not reduce this requirement. • The EndoAnchor™ implant and the Heli-FX™ EndoAnchor™ system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith , Cook Zenith TX2™*, Gore Excluder™*, Gore TAG™*, Medtronic AneuRx™, Medtronic Endurant™ Medtronic Talent AAA, Medtronic Talent™ TAA, Medtronic Valiant Xcelerant , Medtronic Valiant™ Captivia™, and Medtronic Valiant Navion™ endografts. Use with endografts other than those listed above has not been evaluated. • The performance of the EndoAnchor™ implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks. • The performance of the EndoAnchor implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor™ implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures. • The performance of the EndoAnchor™ implant has not been evaluated for securing multiple anatomical structures together. Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events.

MRI Safety and Compatibility: • The EndoAnchor™ implants have been determined to be MR Conditional at 3T or less when the scanner is in Normal Operating Mode with whole-body-averaged SAR of 2 W/kg, or in First Level Controlled Mode with a maximum whole-body-averaged SAR of 4 W/kg. • Please refer to documentation provided by the endograft system manufacturer for MR safety status of the endograft system with which the EndoAnchor implants are being used.

Potential Adverse Events: Possible adverse events that are associated with the Heli-FX EndoAnchor™ system, include, but are not limited to: • Aneurysm rupture • Death • EndoAnchor implant embolization • Endoleaks (Type III) • Enteric fistula • Failure to correct/prevent Type I endoleak • Failure to prevent endograft migration • Infection • Renal complications (renal artery occlusion/dissection or contrast-induced acute kidney injury) • Stroke • Surgical conversion to open repair • Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula • Vessel damage, including dissection, perforation, and spasm Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the Instructions for Use provided with the endograft for additional potential adverse events.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information. CAUTION: EndoAnchor™ implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zones. EndoAnchor™ implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2mm in thickness. Attempting to place EndoAnchor™ implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing. For complete product and risk information, visit medtronic.com/manuals. Consult Instructions for Use at this website. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat Reader® with the browser. Adobe and Acrobat Reader are registered trademarks of Adobe Systems incorporated in the United States and/or other countries.

UC202211045 EN ©2024 Medtronic. All rights reserved. Medtronic and the Medtronic logo are trademarks of Medtronic. ™*Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. For distribution in the USA only. 05/2024

NEW DATA ON TAMBE OUTCOMES IN COMPLEX AORTIC ANEURYSMS

The Food and Drug Administration (FDA)-approved Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE) has been shown to be safe and effective at 30 days for the treatment of patients with complex aortic aneurysms involving the visceral aorta. By Will Date

THIS IS ACCORDING TO FINDINGS of the TAMBE trial, a prospective non-randomized multicenter study investigating the use of the TAMBE device in thoracoabdominal and pararenal aortic patients, enrolled in the U.S. and Europe. Findings of the trial were presented during Thursday’s Plenary Session 4 by Mark A. Farber of the University of North Carolina, Chapel Hill.

TAMBE is an implantable branched device designed for use in patients with thoracoabdominal aortic aneurysms (TAAA) and high-surgical risk patients with pararenal aortic aneurysms (PRAAs) using an endovascular approach.

The device has four built-in precannulated internal portals to facilitate placement of bridging stent grafts into the visceral arteries perfusing the internal organs within the abdomen. FDA granted approval for TAMBE to be used in the

treatment of complex aneurysmal disease in January 2024.

Farber presented the first of two arms of the TAMBE trial, which targeted type IV TAAAs and PRAAs, including 102 patients in total. A secondary arm focused on Crawford type I-III aneurysms is continuing enrollment, having recruited 23 patients so far.

Patients enrolled in the primary arm of the trial had an average age of 73, were predominantly male (84%), and presented with significant cardiovascular risk factors including current smoking (42%) and hypertension (92%). Around 40% of patients were treated for PRAA, with around 60% treated for type IV TAAA, with 83% of the TAAA cohort and 72% of the pararenal group had an aneurysm diameter of >5.5cm.

Technical success of the procedure was achieved in all but one patient, Farber

detailed, adding that there were no access failures, and 407 of the 408 target vessels were successfully stented. Non-TAMBE components were required to be placed in 19 patients.

Following their procedures, patients had a mean length of hospital stay of 4.9 days, with 89.2% of patients discharged to home. No lesion-related allcause mortality or severe bowel ischemia were reported through 30 days.

Reinterventions were required in 9.4% of patients at 30 days, with one devicerelated death reported on post-operative day 39, which Farber commented was likely related to superior mesenteric artery (SMA) stent occlusion. Major adverse events occurred in 6.9% of patients, including two with respiratory failure, one disabling stroke, and two patients having developed new onset renal failure requiring dialysis. Two patients developed paraplegia.

The success of the trial was measured against two composite primary endpoints, one including technical success and procedural safety, and the second reinterventions and lesion-related mortality.

“Overall, 92% of the subjects were free from procedural safety events, however, the uncomplicated technical safety performance goal, 80%, was not met in the study because of the number of unplanned non-TAMBE devices implanted,” Farber detailed.

Patient selection is likely to have had a significant impact on outcomes, and device applicability may not reflect real-world experience, Farber said, outlining some potential limitations of the study.

“The TAMBE device has been shown to be safe and effective at 30 days at treating patients with complex aneurysms involving the visceral aorta,” said Farber. “Outcomes demonstrate a high technical success rate, no 30-day mortality, and a low rate of safety events within 30 days of the index procedure.”

However, he cautioned that the procedure is “not without risk”, citing the occurrence of paraplegia, renal failure, and a need for adjuvant stenting to resolve complications both intraoperatively and in follow-up.“Long-term data will help determine where this treatment strategy will fit in the management of patients with TAAA and PRAA,” he said.

PERIPHERAL IVL

Shockwave Peripheral IVL: Reliably safe. Predictably effective. Backed by real-world and level one evidence, Shockwave IVL modifies both superficial and deep calcium. Designed for the iliacs, fem-pop and below-the-knee arteries, these purpose-built devices come in sizes that allow you to treat calcium at any level. So you can count on affecting outcomes for the better.

Peripheral Important Safety Information

In the United States: Rx only.

Indications for Use—The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

Contraindications—Do not use if unable to pass 0.014” (M5, M5+, S4) or 0.018” (L6) guidewire across the lesion-Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.

Warnings—Only to be used by physicians who are familiar with interventional vascular procedures—Physicians must be trained prior to use of the device— Use the generator in accordance with recommended settings as stated in the Operator’s Manual.

Precautions—use only the recommended balloon inflation medium—Appropriate anticoagulant therapy should be administered by the physician—Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology.

Adverse effects–Possible adverse effects consistent with standard angioplasty include–Access site complications –Allergy to contrast or blood thinner–Arterial bypass surgery—Bleeding complications—Death—Fracture of guidewire or device—Hypertension/Hypotension—Infection/sepsis—Placement of a stent—renal failure—Shock/pulmonary edema—target vessel stenosis or occlusion—Vascular complications. Risks unique to the device and its use—Allergy to catheter material(s)— Device malfunction or failure—Excess heat at target site. Prior to use, please

EARLY VASCULAR EVALUATION CAN ‘SIGNIFICANTLY SUPPLEMENT’ WOUND HEALING AND LIMIT RESOURCE WASTE

“Our findings ultimately suggest that vascular evaluation within six weeks of wound appearance can significantly supplement wound healing in wound centers,” said Saranya Sundaram, MD, vascular surgery resident (PGY-3) at the Medical University of South Carolina in Charleston, presenting data from an 80-limb retrospective analysis during Thursday morning’s Plenary Session 3.

SUNDARAM WENT ON TO RELAY that—based on the study findings—vascular-provider encounters within six weeks of wound appearance may be associated with accelerated time to wound healing; shorter time to wound-healing checkpoints; shorter time to operative intervention; and reduced overall use of wound-clinic resources.

Detailing the backdrop for the present study, the speaker told VAM 2024 that, while some prior data from academic hospital-associated wound care centers have suggested improvements in wound-healing outcomes when wound management is driven by vascular providers, it “remains unclear” whether or not this benefit is derived solely from early vascular provider involvement.

“We studied if simply limiting the time to vascular provider evaluation could benefit wound healing in patients with arterial insufficiency,” Sundaram reported, noting

PAD

that, in this instance, vascular providers were either board-certified vascular surgeons or advanced practice providers with at least five years of vascular experience.

“We also looked at other measures of resource expenditure to determine if additional benefits could be derived in this potential public health target.”

The presenter stated that she and her colleagues examined patients seen at their institution’s wound center from its initial opening in 2022 through its first year (July 2022–July 2023).

In addition, a sensitivity analysis deemed six weeks to be an “appropriate exposure cutoff” after wound appearance. Sundaram and colleagues ultimately identified 45 limbs evaluated within six weeks (early-exposure group) and 35 limbs that were not (late/ no-exposure group).

Similar socioeconomic, medication use

Biologic graft proves ‘resilient’ and safe in bypass treatment for CLTI

THE HUMAN ACELLULAR VESSEL (HAV; HUMACYTE)—A novel, off-the-shelf conduit intended for chronic limb-threating ischemia (CLI) treatments involving infrageniculate bypass—has demonstrated “resilience,” a good safety profile, and “acceptable” secondary patency rates, as per a study featured in yesterday’s Plenary Session 3. Comparative, single-center data presented by Indrani Sen, MBBS, a vascular surgeon at the Mayo Clinic Health System in Eau Claire, Wisconsin, indicated that the HAV provided major amputation-free survival rates that were similar to the great saphenous vein (GSV) at one year—despite the biologic graft only being associated with “modest” primary patency results.

“Based on Kaplan-Meier analysis, at one year, the primary patency of the HAV was lower than the GSV; 36% compared to 50%,” Sen reported. The secondary patency, however, was a little bit better, she observed, adding that this “speaks to the resilience of the graft—and it has withstood both open and endovascular reintervention.” The speaker also noted that major amputation-free survival rates being equivalent between groups can be attributed to good wound care in the study’s HAV cohort. Sen said that lessons derived from these experiences may help to inform the design of a Phase III clinical study evaluating the HAV in patients with less severe disease patterns and no autologous conduit options.

and comorbidity profiles were observed across both groups—and more patients were appropriately managed on aspirin, statins and insulin after establishing care with a wound center.

“While only 80.6% of late-exposure patients were evaluated by a vascular provider, care was more often supplemented by other surgical subspecialties, such as plastic surgery or orthopedic surgery,” Sundaram said, moving onto the study’s results. “Interestingly, only 51.4% of late-exposure patients had ABI [ankle-brachial index] testing available at initial evaluation.”

She went on to detail that more “classical” arterial-wound distribution was observed among the early-exposure patients, versus a more mixed pattern within the late/no-exposure group, although this difference did not reach statistical significance.

Early-exposure wounds, Sundaram continued, grew to be roughly double the maximum size of their later counterparts (27.1cm2 vs. 11.8cm2), despite wound sizes being similar upon initial evaluation (14.3cm2 vs. 10cm2). Baseline wound and

“In terms of resource expenditure, earlier vascular exposure limited the average number of woundcenter visits and procedures”
SARANYA SUNDARAM

ischemia scores also appeared to be significantly higher in the early-exposure group, although infection scores were comparable, as per initial SVS Wound, Ischemia and foot Infection (WIfI) scores.

In addition, baseline non-invasive testing outcomes were similar between groups, as was the rate of patients who ultimately underwent operative intervention during their wound course.

“Kaplan-Meier analysis suggested faster wound healing may be seen in the early-exposure group—however, this difference did not attain statistical significance,” the speaker said.

“Though, when we accounted for possible confounding factors on Cox regression analysis, we did find that earlier vascular exposure was associated with a nearly 2.5-times faster healing rate. And, on a more granular level, established checkpoints associated with wound closure—such as maximum wound size, a size reduction of greater than 15% in one week, presence of greater than 75% granulation tissue within the wound, and evidence of epithelialization—were all achieved at a much faster pace in the early-exposure group.

“In terms of resource expenditure, earlier vascular exposure limited the average number of wound-center visits and procedures— without transposing the burden to surgical-provider visits; though, these patients were more likely to undergo at least one additional operative intervention than their [late-exposure] counterparts. If intervention was indicated, early-exposure patients underwent these procedures within a much shorter timeframe, among either revascularization or debridement [procedures].”

EVAR

ZENITH ILIAC BRANCH GRAFT ‘DURABLE AND HIGHLY EFFECTIVE’ IN PRESERVE II STUDY

FIVE-YEAR OUTCOMES FROM THE PRESERVE II study support the safety and effectiveness of the investigational Zenith iliac branch graft (ZBIS, Cook Medical) in combination with the iCast covered stent (Getinge) to preserve internal iliac artery perfusion during endovascular aneurysm repair (EVAR).

W. Anthony Lee, MD, is set to share this key conclusion during Plenary Session 8 (Saturday June 22, 11:15 a.m.–12:30 p.m., West Building, Level 3, Skyline Ballroom).

The PRESERVE II study evaluated the safety and effectiveness of the ZBIS graft with the iCast stent to maintain perfusion of the internal iliac artery during EVAR in patients with insufficient distal landing zone within the common iliac artery. This study was initiated after device integrity issues were observed using an investigational bridging stent in the PRESERVE I study.

This study was a prospective, multicenter, nonrandomized investigation conducted across 18 U.S. sites. Patients were enrolled between 2014 and 2015, with follow-up conducted out to five years.

Forty patients, the majority of whom (38) were male and with a mean age of 67.8 years, were treated. The study’s primary endpoint of sixmonth freedom from patency-related intervention was 100%, 30-day freedom from morbidity was 85%, and six-month branch vessel patency was 100%.

Lee, who is chief of vascular surgery at Boca Raton Regional Hospital in Boca Raton, Florida, will note at VAM 2024 that five-year follow-up was available in 75% of patients with complete imaging in 65%. He will present the findings that freedom from all-cause mortality at five years was 88.9%, there was no aneurysm-related mortality, and five-year freedom from patency-related intervention was 100%.

In addition, Lee will report that a total of nine patients required 15 secondary interventions, with six ipsilateral to the ZBIS, and that the treated iliac aneurysm size was decreased in 27% of patients and unchanged in 73%. There were no ruptures, type III endoleaks, migrations, or device integrity issues.

One Laser. Multiple Capabilities.

DUAL IMPACT

Fracture medial arterial calcium while debulking intimal morphologies

BELOW THE KNEE

Proven success in below-the-knee arteries, where calcium tends to be more prevalent2

SAFETY

Safety at the forefront. Treat with confidence by minimizing the risk of embolization and dissection3

Caution: Federal (USA) law restricts the use of the system by or on the order of a physician. Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product. INDICATIONS FOR USE

The Auryon Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.

The Auryon Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

1. Rundback et al. Treatment effect of medial arterial calcification in below-knee after Auryon laser atherectomy using micro-CT and histologic evaluation, Cardiovascular Revascularization Medicine, 2023,ISSN 15538389, https://doi.org/10.1016/j.carrev.2023.06.027.

2. Paul D. Bishop, Lindsay E. Feiten, Kenneth Ouriel, Sean P. Nassoiy, Mircea L. Pavkov, Daniel G. Clair, Vikram S. Kashyap, Arterial Calcification Increases in Distal Arteries in Patients with Peripheral Arterial Disease, Annals of Vascular Surgery, Volume 22, Issue 6, 2008, Pages 799-805, ISSN 0890-5096, https://doi.org/10.1016/j.avsg.2008.04.008.

3. Rundback J, Chandra P, Brodmann M, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;94(7):1010-1017.

VAM 202 4

SCHEDULE AT-A-GLANCE

Friday, June 21

6:00 a.m. to 4:00 p.m. Registration

West Building, Level 3, Hall F1 Foyer

6:30 a.m. to 7:15 a.m. International Fast Talk Session West Building, Level 1, W183c

6:30 a.m. to 8:00 a.m. General Surgery Resident Session: How to Succeed as a Vascular Surgery Fellowship Applicant West Building, Level 1, W183a

6:30 a.m. to 8:00 a.m. Medical Students: Introduction to Vascular Surgery West Building, Level 1, W183b

7:15 a.m. to 8:00 a.m. International Forum Scientific Session West Building, Level 1, W183c

8:00 a.m. to 9:30 a.m. Plenary Session 5 West Building, Level 3, Skyline Ballroom W375ab

9:30 a.m. to 10:00 a.m. Coffee Break in the Exhibit Hall West Building, Level 3, Hall F1

9:30 a.m. to 10:00 a.m. Vascular Live Presentation: The Role of Drug-Eluting Resorbable Scaffolds for Infrapopliteal CLTI, Sponsored by Abbott

10:00 a.m. to 11:00 a.m. Plenary Session 6

11:00 a.m. to 12:00 p.m. Presidential Address

12:00 p.m. to 1:30 p.m. Lunch with Exhibitors

12:15 p.m. to 12:40 p.m. Vascular Live Presentation: From Podium to Practice: Embracing TCAR First, Sponsored by Silk Road

12:30 p.m. to 1:30 p.m. Industry Symposia: Organogenesis Presents: Managing Bioburden in Complex Surgical Wounds From The Start

12:30 p.m. to 4:30 p.m. Career Fair

1:00 p.m. to 1:25 p.m. Vascular Live Presentation: Delivering Results in a Hostile Anatomy: How Treatment with the GORE Excluder Conformable AAA Endoprosthesis Achieved Results in Patients with up to 90˚ Necks as Short as 10mm in Length, Sponsored by Gore

1:30 p.m. to 3:00 p.m. Contemporary Management of Carotid Disease After the Coverage Decision Change and Prior to CREST 2 Results

West Building, Level 3, Hall F1

West Building, Level 3, Skyline Ballroom W375ab

West Building, Level 3, Skyline Ballroom W375ab

West Building, Level 3, Hall F1

West Building, Level 3, Hall F1

West Building, Level 1, W184d

West Building, Level 3, Skyline Ballroom W375c

West Building, Level 3, Hall F1

West Building, Level 1, W183a

1:30 p.m. to 3:00 p.m. Key Leadership Topics in Vascular Surgery West Building, Level 1, W183c

1:30 p.m. to 3:00 p.m. Infrainguinal Bypass—How to do it Successfully and Efficiently West Building, Level 1, W183b

1:30 p.m. to 3:00 p.m. PA Section

West Building, Level 1, W184bc

1:30 p.m. to 3:00 p.m. Residency Fair

1:30 p.m. to 3:00 p.m. Young Surgeons Section: “Well, Here We Are, But Right Now I Wish I Wasn’t” –Early Career Errors

3:00 p.m. to 3:25 p.m. Vascular Live Presentation: Baroreflex Activation Therapy: A Novel Extravascular Procedure for Heart Failure Patients, Sponsored by CVRx

West Building, Level 3, Skyline Ballroom W375c

West Building, Level 1, W184a

West Building, Level 3, Hall F1

3:00 p.m. to 3:30 p.m. Coffee Break in the Exhibit Hall West Building, Level 3, Hall F1

3:30 p.m. to 5:00 p.m. Vascular Wound Session 2024: Updates in Maximizing the Value of Wound Care in your Practice West Building, Level 1, W183c

3:30 p.m. to 5:00 p.m. Role of Open Aortic Surgery in 2024 West Building, Level 1, W183a

3:30 p.m. to 5:00 p.m. Understanding the Business Aspects of Vascular Surgery West Building, Level 1, W183b

3:30 p.m. to 5:00 p.m. International Young Surgeons Competition West Building, Level 1, W184bc

3:30 p.m. to 5:00 p.m. Poster Competition West Building, Level 3, Hall F1

3:30 p.m. to 5:00 p.m. Women's Section: Vascular Trauma – What I Need to Know in the Middle of the Night West Building, Level 1, W184a

6:15 p.m. to 7:00 p.m. SVS Foundation Pre-Gala Reception Museum of Science & Industry

7:00 p.m. to 12:00 a.m. SVS Foundation Gala: A Night at the Museum – A Celebration of Science Museum of Science & Industry Saturday, June 22

7:00 a.m. to 1:00 p.m. Registration West Building, Level 3, Hall F1 Foyer

8:00 a.m. to 9:30 p.m. Plenary Session 7 with Continental Breakfast West Building, Level 3, Skyline Ballroom W375ab

9:30 a.m. to 10:30 a.m. Poster Championship West Building, Level 3, Skyline Ballroom W375ab

10:30 a.m. to 10:45 a.m. Coffee Break West Building, Level 3, Skyline Ballroom W375ab

10:45 a.m. to 11:15 a.m. Frank J. Veith Distinguished Lecture West Building, Level 3, Skyline Ballroom W375ab

11:15 a.m. to 12:30 p.m. Plenary Session 8 West Building, Level 3, Skyline Ballroom W375ab

12:30 p.m. to 1:45 p.m. Member Business Luncheon (Members Only) West Building, Level 1, W185bcd The Museum of Science and Industry, site of tonight’s Gala

Young Surgeons to reflect on past ‘errors’

AT 1:30 P.M. THIS AFTERNOON THE SVS Young Surgeons Section (YSS) will hold their educational session, “Well, Here We Are, But Right Now I Wish I Wasn’t”—Early Career Errors.

Earlier in 2024, the YSS held a call for cases, where they invited section members to submit their cases, and other early-career stories for review to be considered for presentation. A total of six speakers will present their “errors.”

The concept of the session was inspired by the popular “My Worst Cases” session, which has become a firm favorite among VAM attendees. However, YSS leadership wanted the young surgeons’ version to have a different twist, with the option to submit nonclinical scenarios for consideration. It will be held in the West Building, Level 1, W184a.

Residency Fair invites medical students, residents

to look at what’s out there

THE ANNUAL RESIDENCY FAIR will take place from 1:30–3:30 p.m. this afternoon. The fair invites medical students and general surgery residents at VAM 2024 to attend and connect with residency and fellowship programs from across the country to help prepare for the next step in their vascular surgery journey. Some 70 programs are scheduled to attend the fair.

Taking the next step

THE SVS INVITES ANYONE looking to take the next step in their career, explore different options and/ or connect with employers to attend the 2024 SVS Career Fair taking place from 12:30–4:30 p.m. this afternoon.

As an extension of SVS Job Bank, the Career Fair will provide an opportunity for employers to meet face-to-face with top vascular surgery professionals and vice versa for anyone on the job hunt. It will take place in West Building, Level 3, Skyline Ballroom W375c.

SVS CENTRAL: HUB OF SOCIETY ACTIVITY IGNITES SPACE OUTSIDE EXHIBIT HALL

THE SVS ARRAY OF DIVISIONS, programs and initiatives traditionally housed in the VAM Exhibit Hall exited stage left for a dedicated hub for the first time at VAM 2023 as the Society launched SVS Central. This year, the setup—located on Level 3 of the McCormick Place West Building, near the registration area—featured a slew of SVS stops for attendees.

SVS Foundation: The philanthropic arm of the Society is stationary within the hub, where staff are prepared to answer any Foundation-centric questions, ranging from the Step Challenge at VAM to tonight’s Gala (tickets are still available). Donations are also accepted at the table.

Journal of Vascular Surgery (JVS): Back by popular demand, the JVS team are found in SVS Central with yet another new sock. JVS staff can answer questions regarding journal subscriptions and/or any of the five publications.

SVS Membership: Anyone looking to become an SVS member, pay their dues, check their membership status or inquire about membership benefits can connect with members of the membership team in SVS Central.

SVS Education: The SVS education team has set up shop at SVS Central to spread the word about their new, returning and useful initiatives and products. Visit the table to learn about—and potentially register for—the September Complex Peripheral Vascular Interventions (CPVI) Skills Course.

SVS Quality Practice: The quality practice team is prepared at their table with copies of the new OBL Handbook available for purchase. The team also has giveaways and is prepared to answer any questions.

SVS PAC: The SVS Political Action Committee (PAC) has set up a lounge area showcasing the 2024 donors with knowledgeable individuals prepared to answer questions. Computers are set up to take donations and scrub caps and pens are available for donors who wish to take one. SVS PAC is the political action committee of the SVS, and its goal is to support and elect pro-vascular surgery candidates at the federal level. Support for SVS PAC is strictly voluntary and you have the right to refuse to participate without any reprisal. Contributions to SVS PAC are not deductible for federal income tax purposes. Only U.S. citizens or persons lawfully admitted for permanent residency (“green card” holders) in the U.S. are eligible to contribute to SVS PAC.

Ensuring vascular fellowship application success

THIS MORNING, A SPECIAL breakfast session for general surgery residents is taking place from 6:30–8 a.m. to walk through those interested in succeeding as a vascular fellowship applicant. The session was put together by the SVS Resident Student Outreach Committee (RSOC).

The session covers a variety of topics, including more exposure to vascular surgery as a general surgery resident, research during general surgery residency, mentorship, how to strengthen the actual application and more.

Moderator Natalie Sridharan,

Women’s Section to place a lens over vascular trauma

THE SVS WOMEN’S SECTION WILL host their VAM 2024 session, “Vascular Trauma: What I Need to Know in the Middle of the Night” at 3:30–5 p.m. on Friday (West Building, Level 1, W184a). The session will feature talks about different vascular trauma types and their guiding principles.

“Vascular trauma is universal and can result in loss of limb or life if not addressed or treated appropriately. When a patient presents with vascular trauma, there are guiding principles for the work up and management of the injury,” said Erica Leith Mitchell, MD, professor and chief of vascular and endovascular surgery at the University of Tennessee Health Science Center in Memphis, Tennessee, one of the session moderators.

Mitchell emphasizes that numerous vascular surgery training programs are not connected to trauma centers, resulting in trainees lacking experience in managing vascular trauma, and how practicing vascular surgeons might not feel assured or skilled in treating these patients. This session aims to provide practical advice for handling vascular trauma and a plat form for discussing difficult cases.

MD, from University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, discussed research opportunities and how they can open doors for residents and fellows during her talk.

“These opportunities are important to strengthen a fellowship application and to more deeply understand and become involved in the field,” she said.

Sridharan emphasized the importance of getting involved with regional societies for both networking and funding opportunities when it comes to research.

THE SVS WILL BE OFFERING ATTENDEES complimentary headshots from 10 a.m. until 2 p.m. today.

The headshot station is located just outside SVS Central near registration. After the conference, the SVS will share headshots with VAM attendees via a link. The headshots may take up to one month after

ALL CREDIT AND CONTACT HOURS FOR VAM 2024, the Vascular Quality Initiative (VQI) and the Society for Vascular Nursing (SVN) must be claimed by July 22. Visit vascular.org/VAM24CME.

Erica Leith Mitchell

VASCULAR GIANTS

Leaders in their field: SVS bestows two awards for lifetime achievement

A STANDING OVATION, FLASHING LIGHTS AND a praiseworthy introduction greeted the recipients of the SVS Lifetime Achievement Award yesterday morning: Peter Gloviczki, MD, and Robert M. Zwolak, MD, took turns to soak in the highest honor a member can receive from the organization.

Greeting them both individually, SVS President Joseph Mills, MD, introduced the two as great leaders of vascular surgery and described the significance of their accomplishments.

“Since its inception in 1998, the SVS Lifetime Achievement Award has celebrated the pinnacle of achievement in our field,” said Mills. “Today, we honor two luminaries who have profoundly advanced vascular surgery and inspired countless colleagues and trainees with their dedication, innovation and leadership.”

Gloviczki has dedicated his career to advancing vascular surgery through clinical practice and academic contributions. His lifetime achievements encompass clinical, scholarly and educational accomplishments, as well as research that has significantly impacted the field. In his acceptance speech,

he reflected on his modest beginnings as an immigrant who aspired to be a surgery professor. He expressed his gratitude to everyone who has supported him along his “unique journey,” from a small town in Northeast Hungary near the Ukrainian border to Rochester, Minnesota, at the Mayo Clinic.

“I have been extremely fortunate to have a great family, my father, uncle and brother—they were all physicians. Somewhere in heaven, my parents are smiling down at me right now,” he said, thanking his parents for being his role models growing up and showering him with love and support. He also thanked his professors, colleagues and wife.

Gloviczki has overseen critical advancements in knowledge and practice as the editor-in-chief of the Journal of Vascular Surgery. He has previously served as SVS president and in various executive positions within the Society. Recently, he completed the 5th edition of the Handbook of Venous and Lymphatic Disorders, a landmark resource.

“I would like to dedicate this award to my residents and fellows, as you are the current and future leaders of this distinguished society; you help and inspire me daily to provide the best care to our patients. I am so proud to have shared this with each and every one of you,” said Gloviczki.

Zwolak used his time at the podium to praise the SVS

“If I could dial the clock back 40 years, would I choose anything different?”
ROBERT M. ZWOLAK

community and call on members to engage now more than ever. He addressed his medical students, residents and fellows in the room, thanking them for choosing vascular surgery as their specialty.

“If I could dial the clock back 40 years, would I choose anything different?” he asked the crowd. “Absolutely not.”

Zwolak detailed the numerous complex procedures that vascular surgeons perform daily and highlighted widespread innovation in the field. He emphasized that, with tools like the Vascular Quality Initiative (VQI), “we meticulously follow up, identify evidence-based practices and establish guidelines for these devices.”

Zwolak is renowned for his dedication to advocating for fair payment for vascular care. His research efforts have led to significant advancements in understanding vascular diseases and treatment methodologies. As a principal investigator on numerous studies, Zwolak has authored influential publications and books that have guided practice and policy in vascular surgery. His work with the Centers for Medicare and Medicaid Services (CMS) and various professional societies has led to crucial changes benefiting patients and healthcare providers. Zwolak’s extensive involvement with the SVS includes numerous leadership positions, including a tenure as SVS president.

“Vascular surgery has been the most gratifying career, and I suspect it will be for you as well,” said Zwolak.

Zwolak reminded the crowd how effective political advocacy can be in support of the vascular community in Washington, D.C., referencing the creation of a federal mandate for abdominal aortic aneurysm (AAA) screening and Medicare beneficiaries.

Peter Gloviczki (left) and Robert M. Zwolak

VAM THROUGH THE LENS »

Scenes from day two at VAM 2024, which featured another busy program schedule with highlights including the John Homans Lecture, plenary sessions focusing on peripheral and aortic disease, the International Poster Competition, and many more. The Exhibit Hall also opened its doors, showcasing the latest advances from industry.

“Vascular surgery has been the most gratifying career, and I suspect it will be for you too”
ROBERT M. ZWOLAK
Following an evening of fun and community building at the SVS Connect@VAM event at Soldier Field, the morning of day two had an international flavour, featuring the International Chapter Forum, and John Homans Lecture, delivered by Maarit Venermo, MD, pictured bottom left, touching on what we can learn from international variations in vascular care.

The shift to outpatient care: ‘A good business plan is mandatory’

DANIEL MCDEVITT, MD, SPOKE DURING yesterday’s Community Practice Section on potential methods to participate in the shift to the office-based lab (OBL) and ambulatory surgical center (ASC). The president of Peachtree Vascular Specialists in Stockbridge, Georgia, shared his opinion that the OBL currently offers the highest reimbursement for the least investment and underscored the necessity of having a strong business plan ahead of making the move to any outpatient setting.

“We’re in challenging times right now,” McDevitt began, citing a continuing decrease in Centers for Medicare and Medicaid Services (CMS) reimbursement and limited time in the operating room and cath lab due to a “substantial reduction” in most hospitals’ workforce since COVID-19 as two of the main reasons behind this.

“The bottom line is, it’s much more difficult to make a living at the hospital,” McDevitt summarized.

In response to this, the presenter noted that many physicians have gone to employment. He went on to note, however, that positions are limited, and stressed that employed surgeons are often asked to do procedures that do not necessarily align with either their interests or their practice focus.

McDevitt went on to say that independent practice has al-

ways been “an escape pod for people [who] are tired of doing what other people have asked them to do” and offers more flexibility in terms of practice goals and lifestyles.

He noted that independent practice can be “financially challenging,” however, due to low reimbursement and escalating overhead costs.

McDevitt then moved on to the benefits and drawbacks of two alternatives: OBLs and ASCs.

With regard to OBLs, the presenter outlined three options: “the first is you can sublet table time or basically rent an OBL, you can purchase an existing OBL, or you can build your own.”

McDevitt noted that subletting an OBL offers an opportunity to “dip your toe in the water” and could provide “a reasonable return” for a relatively low investment.

Purchasing an existing OBL, “may be more realistic now” than it has been in the past due to the financial climate, McDevitt told the VAM audience. However, he stressed the importance of having a strong business plan to make it work.

“Don’t walk into these things without knowing what you’re doing, and always plan for a worse-case scenario,” he advised.

McDevitt then turned to the “most complex” option, which is starting an OBL from scratch.

“I will caution you, you do have to be financially able to withstand the start-up costs,” he said, adding that, “You should already be busy if you’re going to do this.”

In addition, McDevitt highlighted the fact that there would be state regulations to consider.

Moving on to ASCs, the presenter said that “usually the easiest way to go” would be to get staff privileges at an existing ASC.

“You won’t really derive any of the benefits of owning the facility,” he stressed, but emphasized that this option offers “more control over your time” and table access that might not be available at the hospital.

“The bottom line is, it’s much more difficult to make a living at the hospital”
DANIEL MCDEVITT

McDevitt said that buying an ASC is also an option but is one that represents “a pretty substantial financial risk” and warned again about having to “conquer” the regulatory side of things. “Again,” he stressed, “a good business plan is mandatory.” “In my opinion, the OBL is the highest reimbursement for the least investment right now,” McDevitt shared as his key conclusion. He continued: “Building your own OBL is doable, but buying an existing one may be more efficient for you.”

In terms of ASCs, McDevitt’s main take-home message was that these are “intriguing” for their higher reimbursement for some cases, but underscored the fact that they require a “substantial” investment and that the legal environment is “very challenging.”

Daniel McDevitt

SOOVC OUTLINES STRIDES MADE TO PROVIDE PLATFORM FOR SURGEONS CONDUCTING RESEARCH IN THE OBL

THE SVS SUB-SECTION ON Outpatient and Office Vascular Care (SOOVC) Chair Anil Hingorani, MD, used the group’s dedicated VAM 2024 session to focus on the office-based lab (OBL).

“One of the main things we’ve worked on for the last couple of years is research in the OBL space,” he told those in attendance. “We’ve found that few resources are often available for the OBL. We want to give a platform for people already producing work in the OBL space. Maybe you have a database of your lower extremity angioplasties … venous or access cases. Whatever you’re doing, we didn’t find a place where we could present this work.”

Hingorani revealed the availability of the OBL Handbook, with 18 chapters completed last year and four new chapters added since. The handbook is available for purchase at VAM 2024’s SVS Central outside the Exhibit Hall.

The first three presentations were SOOVC Research Seed Grant projects.

Chong Li, MD, a grant recipient from New York University Langone Medical Center, offered insights from a multicenter perspective study on heparin dosing and safety outcomes

TRAINING

‘Implementation of EPAs marks a paradigm shift in how we prepare vascular surgeons’

AS THE LANDSCAPE OF SURGICAL education undergoes rapid evolution, one innovation promises to redefine how future vascular surgeons are trained and certified: Entrustable Professional Activities (EPAs). A group of experts shed light yesterday on their potential to transform surgical training during an afternoon education session.

Described as “the most disruptive innovation in assessment in more than a decade,” Brigitte Smith, MD, from the University of Utah Health, emphasized the pivotal role EPAs have in reshaping competency evaluation. Unlike traditional time-based training, EPAs focus on abilities essential for unsupervised practice, ensuring graduates deliver safe, highquality patient care across diverse settings.

“The implementation of EPAs marks a

during outpatient peripheral vascular interventions.

“Our study aims to investigate the safety and efficacy of low-dose heparin (40 units/ kg) versus high-dose heparin (70 units/ kg) in femoral-based angiograms or venograms,” Li explained. “The objective is to demonstrate the safety of a consistent antithrombotic practice with low heparin dosing compared to high dosing during peripheral endovascular interventions in an outpatient setting.”

The study’s first stage involved a ret rospective review of data collected by the Vascular Care Group, encompass ing seven practices across three states and involving 21 vascular surgeons from 2022–23. Expected to cover 200–300 cases, the study will assess pri mary endpoints, including ischemic and bleeding complications, and sec ondary endpoints, includ ing procedural duration and recovery time.

“The evidence for hep arin dosages is largely from the coronary litera

ture, much of which is dated from inpatient settings or European countries. This study aims to improve procedural safety outcomes by reducing bleeding and ischemic complications while maintaining safety and efficacy,” said Li.

Margaret Tracci, MD, a professor of surgery at UVA at Charlottesville, Virginia, concluded the session by discussing malpractice protection in OBLs.

Unlike hospitals and ambulatory surgery centers (ASCs), OBLs have notable differences in payment structures and regulatory requirements, she said. These labs have fewer resources, and do not have anesthesia services, operating rooms (ORs), blood banks or intensive care units (ICUs). The equipment and supplies available in OBLs are also more limited compared to more extensive medical facilities.

“Safety and patient selection are fundamental in the OBL setting,” Tracci said. “Key principles include understanding the resources and capabilities of the facility, careful case selection and having a robust plan for potential complications.”

She highlighted several key strategies to avoid complications in the OBL setting, and the cornerstone of which is patient selection. She noted that carefully considering patient char-

acteristics and case or lesion specifics is crucial. She also discussed minimizing risk using minor, safe access points, and employing preventive measures such as embolic protection and intravascular ultrasound (IVUS).

Tracci advised having robust protocols for resuscitation, airway management, vascular salvage and patient transfer. Key equipment, such as thrombectomy catheters and medications, should always be accessible, she said. Establishing hospital privileges and transfer agreements is essential to facilitate smooth and efficient patient transfers when needed, Tracci added.

“Nobody is always both lucky and good, so you will have complications. So how do you avoid both the bad outcomes and the lawsuit? Catch your complications. Check the feet before the patient goes home. Maybe do that really good discharge instruction, telling them what to call for if something’s not quite right at home. Do the phone call,” she said.

“One of the main purposes we’ve worked on for the last couple of years is research in the OBL space. We have found that few resources are often available for the OBL” ANIL HINGORANI

PREVIEW

CLAUDICATION

paradigm shift in how we prepare vascular surgeons,” said Smith. “These activities not only assess competence but also define the core of our specialty, setting clear benchmarks for performance.”

EPAs delineate specific tasks that trainees must demonstrate proficiency in before being entrusted with independent practice. The American Board of Surgery (ABS) clarifies that EPAs are not the same as competencies. Instead, they complement competencies by providing a practical way to apply the broad concept of competency in daily practice. This approach, already integrated into general surgery, now positions vascular surgery as the next frontier for this competency-based model.

Smith’s presentation outlined the developmental journey of vascular surgery EPAs and provided insights into their implementation process. With the ABS paving the way in general surgery, the adoption of EPAs in vascular surgery signifies a proactive step toward aligning training with contemporary healthcare demands, Smith said.

“EPAs are not just a new assessment tool; they represent a fundamental evolution in how we prepare the next generation of vascular surgeons,” she added.

RESEARCHERS ADVISE CAUTIOUS APPROACH TO REVASCULARIZATION IN HIGH-RISK INTERMITTENT CLAUDICANTS

IN A STUDY OF MORE THAN 6,000 PATIENTS, RESEARCHERS FOUND THAT progression to chronic limb-threatening ischemia (CLTI) and major amputation was common after endovascular intervention for intermittent claudication, particularly among patients with diabetes and those treated with infrapopliteal endovascular intervention.

Based on these findings, presenting author Midori White, MD, is set to conclude that “care should be taken before performing revascularization procedures in high-risk patients with intermittent claudication” during a presentation in Plenary Session 7 (Saturday, June 22, 8:00–9:30 a.m., West Building, Level 3, Skyline Ballroom).

In the study, White and colleagues used the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network (VQI-VISION) Medicare-linked dataset to assess patients with intermittent claudication and femoropopliteal disease who were treated with endovascular intervention. VQI registry data were used to assess for index interventions and indications, and Current Procedural Terminology (CPT) and International Classification of Disease (ICD)-10 codes were used to assess for indication of progression of disease and reinterventions (both open and endovascular).

There were 6,164 patients with intermittent claudication included in the study, with a mean age of 72 years and 40.3% of whom were female. These patients were treated with femoropopliteal endovascular interventions, including plain balloon only (13.7%), special balloon (44.6%), atherectomy (34.9%) and stent (37.3%), with procedures performed as hospital outpatient (86.6%), and in ambulatory surgery center or office (13.4%).

White, who is a resident at Johns Hopkins Hospital in Baltimore, Maryland, will report that 20% of patients experienced conversion to CLTI at three years, and 1.7% underwent an ipsilateral amputation for intermittent claudication after a median of 2.9 years of follow-up.—Jocelyn Hudson

Anil Hingorani

SEX-BASED DISPARITY AFTER EVAR NOT LIKELY TO BE DUE TO SURVEILLANCE FAILURE

THOUGH WOMEN ARE MORE LIKELY TO HAVE less durable outcomes after endovascular aneurysm repair (EVAR) than men, failure to follow protocols for post-operative imaging surveillance does not appear to be a significant independent mediator of this disparity.

This is according to research presented during Thursday’s Plenary Session 4, which looked at post-EVAR surveillance failure throughout the U.S. Study investigator Rebecca Scully, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, presented the findings of the research, which included all individuals with Medicare fee-for-service insurance undergoing elective EVAR in the Vascular Quality Initiative (VQI)-linked Vascular Implant Surveillance and Interventional Outcomes Network (VISION) from 2010–2019.

“Sex-based disparities in outcomes following abdominal aortic aneurysm (AAA) repair are well documented, however the mechanisms underlying these findings remain largely undefined,” said Scully. “The goal of the current project was to evaluate whether there are sex-based disparities in post-operative imaging surveillance following EVAR and if so to evaluate the impact of those on patient outcomes.”

After applying exclusion criteria, the researchers identified a cohort of over 15,000 suitable patients, 19% of whom were

ENDOLOGIX FAILURE

female. Within the study population, women were slightly older on average than male patients, with an average age of 77 compared to 75 years, Scully detailed, and were more likely to be current smokers or have chronic obstructive pulmonary disease (COPD). Male patients were more likely to have a diagnosis of coronary artery disease or congestive heart failure.

“Initial surveillance was approximately 77% in both groups,” detailed Scully, noting that with time, imaging surveillance failure increased dramatically, and women were slightly more likely to experience surveillance failure as compared to men. As in previous studies, the investigators also observed an increase in the risk of mortality in female patients compared to men following EVAR.

“In adjusted analysis we did see a slightly increased risk of mortality as well as rupture following EVAR for women

“Surveillance failure in these data does appear to have an impact on mortality following EVAR, however sex does not appear to be a significant independent mediator of that”

Consider explant to repair failing AFX AAA grafts

GRAFT EXPLANT MAY BE THE most durable option for the repair of failing AFX abdominal aortic aneurysm (AAA) endografts (Endologix), but the strategy carries a high risk of perioperative mortality.

This was among the conclusions presented by Michael P. Bianco, MD, a resident at Maine Medical Center in Portland, Maine, who shared his center’s 10-year experience in remediation for AFX graft failures, comparing relining with a contemporary endograft to open graft explant. The Food and Drug Administration (FDA) issued safety alerts regarding the potential for endoleaks with AFX endovascular grafts in June 2018 and October 2019, and its guidance emphasizes the importance of at least yearly, lifelong follow-up for patients who have any type of AFX endovascular graft in order to monitor for type III endoleaks. Bianco’s presentation included data from 55 patients who had remediations on their previously placed AFX grafts. Of these patients, 39 were remediated with a reline, and 16 with explants. The

original AFX stent graft was placed between 2011–2019, with all remediations performed through to April 2024. Bianco’s patient cohort had a median follow-up of 36 months.

Age, race, gender and comorbidities were comparable between the two cohorts, though there were more current smokers in the explant group, Bianco detailed, noting that remediated AFX graft type, endoleak type and AAA diameter were also similar between the cohorts.

“There are a significant amount of juxtarenal and pararenal aneurysms in the explant cohort, and there is a significantly larger amount of patients who presented with late sac rupture who underwent graft explant,” he said.

“Perioperatively, as expected graft relines had significantly better outcomes in mortality, operative time, blood loss, transfusion requirements, hospital length of stay, ICU [intensive care unit] length of stay, postoperative mechanical ventilation and the number discharged to home,” Bianco detailed.

Turning to the primary composite

as compared to men,” said Scully. “However, when imaging surveillance failure was added to the model there was no change in the point estimate for hazard ratios for the impact of post-EVAR risk of death or rupture.”

This suggests, she commented, that while patient sex is a risk factor for death following EVAR, imaging failure does not appear to be a mediator of that effect.

“Durable EVAR outcomes are less likely among female patients as compared to males in current practice,” Scully said. “Surveillance failure in these data does appear to have an impact on mortality following EVAR, however sex does not appear to be a significant independent mediator of that.

“Efforts designed to enhance compliance with post-procedural imaging surveillance in patients may be an opportunity to improve current AAA outcome delivery, however, addressing this may not address sex-based disparities in outcomes.”

In the discussion that followed the presentation, Scully said that the researchers had been surprised by their findings, as although there did seem to be a difference in follow up between male and female patients, there did not seem to be an interaction between surveillance failure and patient gender.

“Obviously we do see differences in outcomes between male and female patients, it just doesn’t seem like the interaction is there with surveillance failure. There is something else going on,” she said.

Scully noted that there were anatomical differences noted between the male and female patients, including that female patients often had shorter and smaller necks, and female patients often were older and more comorbid.

“I think we see that it in practice also, I think we are recognizing aneurysms slightly later in life in women. I think they are a little bit sicker when we treat them and then concurrently they have somewhat worse outcomes,” Scully commented. “COPD rates in female patients were much higher and we all know people do worse with that.”

“ Graft explant is the most durable option for repair of failing AFX devices, however graft explant has a high risk of perioperative mortality”

endpoint, reintervention-free survival, he detailed that after the early perioperative risk for open graft explant, open repair remained durable compared to endograft reline which carries a low perioperative mortality, but a high rate of reintervention and additional procedures. No reinterventions were

seen in the explant cohort. “Compared to the primary composite endpoint, overall survival becomes similar after 24 months of follow-up, however unlike the primary composite endpoint the survival curves never cross,” Bianco said. “The reline cohort did demonstrate an advantage in aneurysm related mortality.”

Bianco did note that the limitations of the research include the retrospective, single-center design of the study, which also has a small sample size and carries a bias towards explanting sac ruptures.

“Graft explant is the most durable option for repair of failing AFX devices, however graft explant has a high risk of perioperative mortality,” Bianco said.

“Relining of failing AFX devices with a second endograft is a safe alternative, but carries a significant risk of continued sac growth requiring additional reinterventions. Elective remediation for the Endologix AFX device should be considered and that minimum enhanced surveillance protocols should be employed.”

Detailing how his team applies these findings in their current practice, Bianco noted that the algorithm employed by the Maine Medical Center team sees explant preferred in physically fit patients, patients with poor proximal seal, or patients with sac growth without an identifiable endoleak on imaging.

Rebecca Scully
Michael P. Bianco

Medical Editor Malachi Sheahan III, MD

Associate Medical Editors

Bernadette Aulivola, MD | O. William Brown, MD | Elliot L. Chaikof, MD, PhD

| Carlo Dall’Olmo, MD | Alan M. Dietzek MD, RPVI, FACS | John F. Eidt, MD | Robert Fitridge, MD | Dennis R. Gable, MD | Linda Harris, MD | Krishna Jain, MD | Larry Kraiss, MD | Joann Lohr, MD

| James McKinsey, MD | Joseph Mills, MD | Erica L. Mitchell, MD, MEd, FACS

| Leila Mureebe, MD | Frank Pomposelli, MD | David Rigberg, MD | Clifford Sales, MD | Bhagwan Satiani, MD | Larry Scher, MD | Marc Schermerhorn, MD | Murray L. Shames, MD | Niten Singh, MD | Frank J. Veith, MD | Robert Eugene Zierler, MD

Resident/Fellow Editor

Christopher Audu, MD

Executive Director SVS

Kenneth M. Slaw, PhD

Senior Director for Public Affairs and Advocacy

Megan Marcinko, MPS

Manager of Marketing

Kristin Spencer

Communications Specialist

Marlén Gomez

Published by BIBA News, which is a subsidiary of BIBA Medical Ltd.

Publisher Stephen Greenhalgh

Content Director Urmila Kerslake

Global Commercial Director

Sean Langer

Managing Editor Bryan Kay bryan@bibamedical.com

Editorial contribution Jocelyn Hudson, Will Date, Jamie Bell, Brian McHugh, Éva Malpass and George Barker

Design Terry Hawes

Advertising Nicole Schmitz nicole@bibamedical.com

Letters to the editor vascularspecialist@vascularsociety.org

BIBA Medical, Europe

526 Fulham Road, London SW6 5NR, United Kingdom

BIBA Medical, North America

155 North Wacker Drive – Suite 4250, Chicago, IL 60606, USA

Vascular Specialist is the official newspaper of the Society for Vascular Surgery and provides the vascular specialist with timely and relevant news and commentary about clinical developments and about the impact of healthcare policy. Content for Vascular Specialist is provided by BIBA News. Content for the news from SVS is provided by the Society for Vascular Surgery. The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or the Publisher. The Society for Vascular Surgery and BIBA News will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services, or the quality or endorsement of advertised products or services, mentioned herein. | The Society for Vascular Surgery headquarters is located at 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | POSTMASTER: Send changes of address (with old mailing label) to Vascular Specialist, Subscription Services, 9400 W. Higgins Road, Suite 315, Rosemont, IL 60018. | RECIPIENT: To change your address, e-mail subscriptions@bibamedical.com | For missing issue claims, e-mail subscriptions@bibamedical. com. | Vascular Specialist (ISSN 1558-0148) is published monthly for the Society for Vascular Surgery by BIBA News. | Printed by Ironmark | ©Copyright 2024 by the Society for Vascular Surgery

AV ACCESS

New comparative study shows no difference between HeRO and fAVG

A NEW CONTEMPORARY COMPARATIVE STUDY WILL BE presented during Friday’s Plenary Session 5 (8–9:30 a.m., West Building, Level 3, Skyline Ballroom) by author Theodore H. Yuo, MD, assistant professor at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania. It will explore the creation of upper extremity arteriovenous (AV) access ipsilateral to central venous lesions, the options that are available in these cases, and how femoral AV grafts (fAVG) and the Hemodialysis Reliable Outflow (HeRO) device are both “valid” options for use in these cases, despite historically poorer outcomes.

Discussing their single-center, retrospective analysis of consecutive use of fAVG and HeRO, Yuo details that their evaluation concerned index AV accesses placed between 2014 and 2023. Cases were identified using the local Vascular Quality Initiative (VQI) database and supplemented by a review of surgeon case logs. Medical history, demographics and operative details were obtained utilizing a combination of VQI data and electronic medical records. Data were analyzed using standard statistical tests, Kaplan-Meier survival estimates, and multivariate Cox proportional hazards (PH) and logistic regressions.

30 days occurred more frequently in the fAVG group. They stated that multivariate logistic regression also suggested that fAVG was associated with increased 30-day mortality.

When following up with the study participants one year after undergoing successful hemodialysis, primary, primary-assisted, and secondary patency rates were higher in the fAVG group. Multivariate PH analysis of the study results suggested that primary and primary assisted patency were similar in both groups, while fAVG was associated with improved secondary patency. Finally, the study also showed that graft removal due to infection occurred more frequently in the fAVG group. The researchers concluded that, in this contemporary series comparing fAVG and HeRO, there were no differences in primary and primary-assisted patency. They did, however, find that there was improved secondary patency among the fAVG patients, as well as the fact that fAVG were associated with higher rates of perioperative mortality and graft infection.

Speaking to VS@VAM about the study, Yuo said: “The HeRO graft and femoral AVG are both reasonable options for ESKD [end-stage kidney disease] patients who are not candidates for standard upper extremity AV access.” He added, “This study evaluating our contemporary experience at UPMC reinforces their relative equivalence, though femoral AVG may have longer secondary patency. HeRO grafts enable extended use of the upper extremity, avoiding use of the lower extremity and the accompanying risks of that anatomic location.”

To conduct the study, data for 99 patients were collected (57 HeRO, 42 fAVG), with a median follow-up of 464 days. Between the groups, there were no differences in female sex at birth and being non-White. Yuo et al found that the patients who received the HeRO were older, had higher body mass index (BMI), had fewer previous AV accesses, and were more likely to be diabetic. They also found that the ability to use the AV access for hemodialysis was similar in both groups, and mortality at

INTERNATIONAL FORUM

THE COLOMBIAN CHAPTER STRATEGY:

‘WE’VE GOT TO GET THE WORD OUT’

THE INTERNATIONAL CHAPTER

Forum Educational Session yesterday morning saw Ana M. Botero, MD, chief of vascular surgery at Fundación Santa Fe de Bogotá in Bogotá, Colombia, speak on the evolution of the SVS Colombian Chapter.

“We’re people that do lots of work, but we’re not in the game yet,” Botero began, in a section of her talk outlining “the Colombian problem.” The presenter continued: “We don’t know how to value ourselves, so being here [at VAM] brings us a lot of connections and that’s something that I’m pretty grateful for.”

In addition to networking opportunities, the presenter underscored the importance of the SVS on the world stage, highlighting its synonymity with education, publications, journals, conferences, online courses, research and support.

“HeRO grafts enable extended use of the upper extremity, avoiding use of the lower extremity, and the accompanying risks of that anatomic location”
THEODORE H. YUO

The focus of Botero’s talk then moved from problem to opportunity.

“There [are] many surgeons that paved the way,” she said. “Seeing somebody that looks like you, talks like you, and is an amazing surgeon outside of Colombia is very important.”

Botero noted that the Chilean Chapter played a significant role in laying the foundations for the Colombian Chapter. She recalled thinking: “Chileans got into the SVS as the Chilean Chapter, so the idea came right away—why not Colombia?”

Botero shared that, around six years ago, “people started sending emails, asking questions about how to get people from Colombia into the SVS,” which she noted resulted in a “very beautiful” collaboration with the society.

“Seeing somebody that looks like you, talks like you, and is an amazing surgeon outside of Colombia is very important”
ANA M. BOTERO

In terms of what to expect from this sort of collaboration, Botero urged members “don’t be shy” and to ask questions.

“SVS is a huge platform, so take it. And for LATAM [Latin America], everything is possible, so let’s do it, let’s take this,” she continued.

In the discussion following Botero’s presentation, one audience member asked how to approach the challenge of ensuring members enjoy the full benefits of SVS membership.

“I think that we’ve got to get the word out,” Botero responded.

“People are scared of being here, in these sorts of spaces. The language barrier is something that is pretty important for us, but I think that once you get here and you get to talk and you get to see people who look like you, talk like you and are able to be here without any reservations, well then you get the courage to do it.”

Theodore H. Yuo
Ana M. Botero at the podium

Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.